According to a recently published article in Targeted Oncology, the results of the Phase III CANDOR trial were presented at the 61st ASH annual conference in Orlando, Florida.
The life expectancy of multiple myeloma patients, thanks in part to the drugs bortezomib and lenalidomide, has improved. However, the benefits are short-lived and the disease remains incurable.
About the CANDOR Trial
The trial (NCT03158688) involved 466 multiple myeloma patients at 102 facilities throughout the world. The median age of the participants was sixty-four. A majority of these patients had relapsed and had become resistant (refractory) to bortezomib and lenalidomide. The doctors and patients were aware of the therapy being administered (open-label) and the patients were selected by chance to minimize bias (randomized). The drugs that were administered were daratumumab, carfilzomib, and dexamethasone.
The triple combination was compared against two drugs: dexamethasone (an anti-CD38 monoclonal antibody) and carfilzomib (a proteasome inhibitor) administered to another group of patients.
The triple combination proved to be superior, with the addition of daratumumab resulting in a thirty-seven percent reduction in the risk of death or disease progression.
The patients who were on the triple-drug combination were in treatment for seventy weeks versus forty weeks of treatment for the two-drug arm.
Researchers conducted a follow-up at the seventeen month mark but the median overall survival (OS) had not yet been reached in either arm of the study. The rate of undetectable MRD (minimal residual disease) in the triple-drug group was almost ten times higher than the two-drug arm.
About Adverse Events (AEs)
AEs were manageable and consistent with the safety profiles previously reported for each drug. The most common AEs were diarrhea, anemia, low white blood counts (thrombocytopenia), hypertension, fatigue, and infections in the upper respiratory tract.
The rate of treatment discontinuation due to AEs was similar in both arms. Cardiac events occurred in five to eight percent of patients, with the triple-drug combination reporting lower numbers of heart failure than the two-drug arm.
Five treatment-related deaths in the triple-drug group were reported. The cause of the deaths were sepsis, pneumonia, cardiac arrest, and septic shock infection.
Dr. Saad Usmani at the Levine Cancer Institute is the author of the study. Dr. Usmani explained that myeloma is a diverse disease with many different clones. This calls for targeting various mechanisms of action. He believes that the addition of daratumumab added to carfilzomib and dexamethasone shows some potential to control the disease.